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概要

A South East Asia Multi-Country Survey Assessing Awareness and Preparedness of the Clinical Investigation Staff on Risk Based Monitoring (RBM) Approach

Karthikeyan Kumar*, Manoj P Jadhav

Background: Patient safety being paramount, the global agencies (US-FDA, EMA, MHRA, ICH) have developed various guidance to improve clinical trials quality, conduct, performance and assess these on risk based principles. Among these, Risk Based Monitoring (RBM) has gained a considerable traction globally to be implemented across all phases of clinical trials.

Methods: A multi-type survey questionnaire containing 19 elements was developed, validated, and circulated among clinical trial staff, between July 2016-June 2017. The survey consisted questions pertaining to responder’s sex, role, trial experience in past 5 years, utilization of RBM tools, type of trials involved in RBM, opinion on better type of monitoring, timely oversight of trial data by RBM, implications of RBM in subject’s safety, data quality, overall efficiency, cost specifications, understanding of RBM methodologies and its future evaluation, readiness to adopt RBM and anticipating challenges in RBM strategies. The survey responses were collected, compiled and entries were verified by third party, and analyzed.

Results: Overall 502 responses were received from 3 countries selected i.e. India (n=282), Malaysia (n=207) and Singapore (n=13); all responses were complete except one. In the survey, 260 (51.79%) males and 242 (48.21%) females participated. Among the responders 114 (28.69%) were investigators, 153(30.48%) were coordinator/research nurse, 134 (26.69%) were CRO personnel and 71 (14.14%) were other clinical staffs. 208 (80%) male participants and 181 (74.79%) female participants were aware about RBM awareness and it was proportionate with number of years of clinical trials experience. Overall, RBM awareness among the responders was 77.49% (n=389). Among the two groups i.e. responses received from Malaysia+Singapore (MS) and India, awareness rate among Investigators MS was 47.88% (n=34) and in India was 65.75% (n=48), among coordinator/research nurse it was 63.95% (n=55) and 85.07% (n=57), among CRO personnel it was 95.24% (n=40) and 95.65% (n=88) and with other clinical staffs it was 90.48% (n=19) and 96% (n=48) respectively. The awareness rate among investigators and coordinator/research nurse was significantly varied between two groups (p<0.03 and p<0.003) respectively. When asked if you will be ready to adopt the RBM concept, 60.45%% (n=133) from MS and 76.59% (n=216) of the participants from India agreed to adopt, 26.36% (n=58) and 12.05% (n=34) were neutral and 10.45% (n=23) and 7.09% (n=20) were not sure about it.Additionally, 77% of the responders agreed on adopting hybrid monitoring (onsite+ remote) approach and if embraced by sponsors this new approach of RBM can improve the trial conduct and minimize the risks. Chi’s Square or Fisher’s exact test used to analysis the significance between twogroups, the significance rate of p<0.001 was determined for demographics, trials involved in past 5 years, trials involve RBM, cost management via RBM, and anticipating challenges in RBM also.

Conclusion: This multi country survey carried out across three countries indicated the need for a structured education, training and a phased wise implementation of RBM. Key finding was willingness of study staff for implementation of hybrid model of RBM guidance with an objective to improve better safety of study participants and improved clinical trials data quality and conduct. This warrants more studies with larger sample size to generate robust evidence.